GRI Bio, Inc. 8K

GRI Bio reported new Phase 2a biomarker, mechanistic, and exploratory lung function data for its IPF candidate GRI-0621, presented at the 2026 ERS Congress, indicating a potential repair phenotype, favorable FVC trends, and good tolerability that support progressing to a longer 52-week study.

On September 8, 2026, GRI Bio, Inc. announced and described new translational biomarker and exploratory lung function data from its randomized, double-blind, placebo-controlled Phase 2a GRI-0621-IPF-02 study of GRI-0621 (oral tazarotene) in idiopathic pulmonary fibrosis, presented in a late-breaking oral session and three posters at the 2026 European Respiratory Society Congress; the data integrate four measurement modalities to define nine mechanistic pillars suggesting an anti-fibrotic repair phenotype, show numerically favorable forced vital capacity (FVC) responder and decline rates versus placebo after 12 weeks, and demonstrate a favorable safety and tolerability profile that the company believes supports advancing GRI-0621 into a longer-duration, 52-week study in IPF, including in combination with standard-of-care antifibrotic therapies pirfenidone or nintedanib.

Filing Facts

CIK

1824293

Ticker

-

Form

8K

Source Type

sec

Accession

0001824293-26-000057

Alert Tier

6